(69 days)
The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.
The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.
The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a study.
Specifically, the document states:
- "Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices. Because that, performance data were not required."
Therefore, I cannot fill out the requested table and information.
If there were performance data, the table would look like this:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [Criterion 1] | [Performance 1] |
| [Criterion 2] | [Performance 2] |
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992707
OCT 1 9 1999
510(k) SUMMARY AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM
This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | AESCULAP-MEDITEC GMBH |
|---|---|
| Address: | Prussingstrasse 4107739 Jena, Germany |
| Contact Person: | Dr. Dirk ColditzQuality Management Representative |
| Phone: | +49 3641 65 3453 |
| Fax: | +49 3641 65 3815 |
| e-mail: | ctz@aesculap-meditec.com |
| Preparation date: | July 25th, 1999 |
| Device name: | DERMABLATE ER:YAG LASER SYSTEM |
| Common Name: | DERMABLATE ER:YAG LASER SYSTEM |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology (21 CFR 878.4810)Product code: GEX - Laser instrument, surgical, poweredPanel: SU |
| Legally marketed: | Sharplan Silktouch CO2 Flash Scanner, Coherent UltrapulseCO2 Surgical Lasers, Ultrapulse S Series CO2 Surgical Lasers |
| Description: | The laser system DERMABLATE ER:YAG LASER SYSTEM isan Erbium:YAG laser with a wavelength of 2.94µm. |
| Intended Use: | The laser system DERMABLATE ER:YAG LASER SYSTEM isintended for laser assisted site preparation for hairtransplantation. All other intended uses are part of 510(k)submission No. K980361 and are note changed or affected bythis indication for use. |
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- The specifications of the laser system DERMABLATE ER:YAG Comparison to: LASER SYSTEM are the same as or very similar to those of legally marketed lasers such as Sharplan Silktouch CO2 Flash Scanner, Coherent Ultrapulse CO2 Surgical Lasers, Ultrapulse S Series CO2 Surgical Lasers.
- Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices.
Because that, performance data were not required.
- The DERMABLATE ER:YAG LASER SYSTEM used for laser CONCLUSION: assisted side preparation for hair transplantation is substantially equivalent to legally marketed devices, e.g. Sharplan Silktouch CO2 Flash Scanner, Coherent Ultrapulse CO2 Surgical Lasers, Ultrapulse S Series CO2 Surgical Lasers.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its body and wings. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1999
Aesculap-Meditec North America c/o Mr. William Kelley 2525 McGaw Avenue Irvine, California 92623-9791
Re: K992707 Trade Name: Dermablate Er: Y AG Laser System Regulatory Class: II Product Code: GEX Dated: July 25, 1999 Received: August 11, 1999
Dear Mr. Kelley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. William Kelley
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _K 952707
Device Name: DERMABLATE ER: YAG LASER SYSTEM
Indication For USE Statement:
The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.
The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Devices K992707
510(k) Number
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.